plc
Annual Reports &Accounting 2011 because people depend on us.
Expanding, Developing, Partnering, Delivering.
we are
We are a growing international specialist healthcare company focused on specialty pharmaceuticals and interventional medicine. Our mission is to bring to market medical products that meet the needs of specialist physicians and their patients and in doing so to build a sustainably profitable business that delivers superior returns to shareholders.
expanding
We are expanding. In the past year we began selling our own specialty pharmaceutical products in the US and we acquired Biocompatibles International plc, addinag an interventional medicine focus.
products & availability 4
2 1
6
5
8 3
Product CroFab速(crotalidae polyvalent immune fab (ovine)) DigiFab速(digoxin immune fab (ovine)) Bead BlockTM LC BeadTM1 DC Bead速 *Products may only be available in some territories in the regions highlighted.
7
Available in regions* 1 1,2,4 1,2,3,4,5,6,7,8 1 2,3,4,5,6,7,8
expanding Acquisition of Biocompatibles, Jan 2011 Acquisition of Protherics, Dec 2008 Over the past 30 months, we have brought together three strong companies – BTG, Protherics and Biocompatibles – to create a growing, international specialist healthcare company, focused on specialty pharmaceuticals and interventional medicine. We will support growth in both areas by investing in product acquisition, development and direct, customer-facing activities. Specialty pharmaceutical products On 1 October 2010, our new acute care sales force commenced selling CroFab® (crotalidae polyvalent immune fab (ovine)) and DigiFab®(digoxin immune fab (ovine)) in the US. CroFab®is approved in the US for the management of patients with North American crotalid snake envenomation. DigiFab®is approved in the US for the treatment of patients with life-threatening or potentially life-threatening digoxin toxicity or overdose; it is also approved in Canada and Switzerland.
Interventional medicine products Through the acquisition of Biocompatibles in January 2011, we now have a range of implantable products to address the needs of patients with cancer of the liver and prostate. These include embolisation beads and drugeluting beads that are guided into arteries supplying tumours, most frequently liver tumours. Embolisation beads block the blood supply and drug-eluting beads slowly release cytotoxic drugs. Biocompatibles also brought delivery systems containing radioactive Seeds and ancillary equipment used in brachytherapy implants to treat early-stage prostate cancer. In addition to strengthening our sales in Western markets, Biocompatibles’ products also provide a footprint in increasingly important Asian markets.exploring additional opportunities in other markets.
Building our product portfolio We intend to expand our product range through organic development and acquisition activities. From our own pipeline, if we are successful in gaining regulatory approvals in the US, potential additions to our marketed products are Voraxaze®(glucarpidase), which is under development for the rapid and sustained reduction of toxic methotrexate levels due to impaired renal function, and Varisolve®(PEM), an experimental treatment for varicose veins. Glucarpidase would be sold by our existing acute care sales force and we would establish a new specialist sales force within our interventional medicine area to market PEM in the US reimbursed sector. We are also seeking to acquire products from outside BTG that fit our specialty pharmaceuticals and interventional medicine franchises, or which merit a dedicated specialist sales force.
developing We are developing products to be used by specialist physicians and that we will market ourselves. We are also developing products addressing major indications that we intend to partner. We developed and we manufacture our marketed products CroFab® and DigiFab®, which are based on our polyclonal antibody platform. We have also developed and manufacture embolising beads and drug- eluting beads for treating tumours, in particular liver cancer, and brachytherapy products that are used in the treatment of early-stage prostate cancer. Our current development programmes support expansion of our marketed products and provide partnering opportunities.
Recent progress in clinical development programmes includes: Voraxaze®(glucarpidase): We expect to submit the final components of the rolling Biologics License Application (BLA) in the US in early H2 2011. This is to seek approval as a treatment for the rapid and sustained reduction of toxic methotrexate levels due to impaired renal function.
recruited 220 patients (96% of target) and VANISH-1 has recruited 62 patients (25% of target). As treatments complete in VV017 a number of VV017 sites will immediately begin recruiting for VANISH-1, increasing the overall number of sites in this study. All studies are expected to be completed by the end of 2011, with data in H1 2012, a US regulatory submission in H2 2012 and potential approval in H2 2013.
DC Bead®, HCC (downstage to resection): A single centre investigator-led Phase II study is currently recruiting patients in the US.
DC Bead®, mCRC (PARAGON): Four investigator-led Phase II studies are recruiting patients covering all stages of metastatic colorectal cancer: neoadjuvant, first line, second line and refractory. The neoadjuvant study is a single arm, multicentre study in patients with resectable liver metastases DC Bead®, HCC (SPACE trial): In from colorectal cancer; the first line study Varisolve®(PEM): Three Phase III trials collaboration with Bayer this Phase II is a randomised multicentre study with were initiated in the US during September study of patients with hepatocellular concomitant systemic oxaliplatin, fluorouracil to November 2010, two (VANISH-1 and carcinoma (HCC) is exploring the use of and leucovorin chemotherapy with antiVANISH-2) are intended to support a US sorafenib in combination with transarterial angiogenic therapy; the second line study is regulatory application for approval as a chemoembolisation (TACE) using the DC a randomised multicentre study of DC Beads single agent to treat the symptoms and Bead®compared with DC Bead®alone. with irinotecan and systemic cetuximab vs. appearance of varicose veins in people with Recruitment is complete and the study results systemic irinotecan and cetuximab in patients incompetence of the great saphenous vein are expected in H1 2012. with refractory KRAS wild type tumours; and (GSV), and the third (VV017) to support an the refractory study is a single arm study in application for use alongside heat ablation of DC Bead®, HCC (bridge to transplant): patients with liver dominant disease. the GSV to treat vein segments not treated Two investigator-led Phase II studies are by the ablation procedure. Recruitment in currently recruiting patients, a multicentre all three is on track: VV017 has completed study in Germany and single centre study in recruitment of all 105 patients, VANISH-2 has New Zealand.
delivering We are delivering against the key corporate objectives supporting our overall goal of becoming a sustainably profitable specialist healthcare company. We now have a US commercial infrastructure, and on 1 October 2010 our new acute care sales force started selling CroFab®and DigiFab®. In January 2011, we completed the acquisition of Biocompatibles and its range of interventional oncology products. We expect to increase revenue and gross margins by optimising our US commercial arrangements and taking over direct sales of the Bead products in the US when the current distribution arrangement expires at the end of 2011. In our pipeline, we decided to complete regulatory development of Varisolve® (PEM) in the US – an investment of around $55m over three years – and initiated three Phase III trials between September and November 2010. If approved, we plan to market PEM ourselves in the US for the treatment of symptomatic varicose veins, where reimbursement is available and where we estimate the peak sales opportunity for PEM to be $250m to $500m per annum. Other pipeline investments are to support the approval of new and existing products. These investments also support the generation of data to enable licensing of products that address major indications and are more appropriate for partnering.
Key performance indicators and priorities for the year: We use financial and non-financial indicators to monitor company performance. The key financial indicators are revenue, gross margin, operating profit and cash. Similar key performance indicators (KPIs) are used in the annual bonus scheme (see the remuneration report on pages 57 to 68). Threshold, target and stretch levels are set, based on the Group’s annual budget. The threshold must be reached for any bonus to be payable; the actual performance determines the bonus element relating to company performance. Results for the financial KPIs are shown in the table below. The non-financial indicators approved by the Board are cascaded into team and individual goals. Progress against these goals determines the personal element of an individual’s bonus. Performance against priorities for 2010/11 and priorities for 2011/12 are shown opposite. Financial KPIs
2010/11
2009/10
Revenue Gross margin Operating profit1 Cash and cash equivalents2
£111.4m 69.4% £1.7m £73.9m
£98.5m 66.7% £10.8m £82.6m
1 2
Theoperatingprofitorlossbeforeacquisitionadjustmentsandreorganisationcosts. 2010/11numberincludescashheldonfixedtermdeposits.
In May 2009 we set out our growth strategy, which had three components: 1. Establish a US commercial infrastructure and sales force to sell both CroFab®and DigiFab®; 2. Acquire additional products to leverage this commercial infrastructure; and 3. Invest in our pipeline to build future value. These led to our priorities for 2010/11, progress against which is shown below. Priorities in 2010/2011
Performance
1. Financial management1 A. Achieve revenue, gross margin, profit and cash targets B. Achieve new licence revenue targets
1. Financial management Achieved Not Achieved
2. Commercial A. Initiate sales of CroFab®and DigiFab® B. Successful audit of compliance systems C. Progress DPC CroFab®for 2012 introduction(project replaced)
Achieved Achieved Not Achieved (project replaced)
3. Growth A. Expand marketed products and pipeline in line with strategy
Achieved
4. Development A. Progress Varisolve®(PEM) Phase III programme B. Submit final part of Voraxaze® (glucarpidase) BLA 5. Operations A. Manage supply chain to meet commercial production targets B. Achieve targeted increases
1
Priorities in 2011/2012
Achieved Not Achieved (submissions delayed to include additional data)
Partially Partially
A. Achieve revenue, gross margin, profit and cash targets B. Deliver acquisition synergies 2. Specialty pharmaceuticals A. Deliver production, revenue and profit targets for CroFab®and DigiFab® B. Submit Voraxaze®(glucarpidase) BLA 3. Interventional medicine A. Deliver production, revenue and profit targets for Beads and BrachySciences B. Ensure readiness to sell LC BeadTM directly in the US from 2012 C. Progress Beads expansion in Asian Markets D. Complete all patient treatments in Varisolve® (PEM) Phase III trials 4. Licensing and biotechnology A. Deliver targets from out-licensing/sale of pipeline assets B. Develop CellMed R&D/partnering plans C. Meet R&D programme timelines 5. Corporate A. Audit quality systems B. Audit global health and safety and environmentalpolicies and procedures C. Grow company through product acquisitions
A detailed review of the financial performance is included in the financial review on pages 21 to 24.
board of directors John Brown Chairman John Brown, PhD, MBA, FRSE, joined the Board of BTG in January 2008 and was appointed non-executive Chairman in March 2008. He is the Chairman of the Nomination Committee. John is Chairman of Axis-Shield plc and a non-executive director of Vectura Group plc. He is Chairman of the Roslin Foundation and a non-executive director of the Technology Strategy Board. Until late 2003, John was Chief Executive of Acambis plc. He is a Fellow of the Royal Society of Edinburgh and an Honorary Professor of the University of Edinburgh.
Louise Makin Chief Executive Officer Louise Makin joined BTG as Chief Executive Officer in October 2004 and she is a non- executive director of Premier Foods plc. From 2001, she was President, Biopharmaceuticals Europe of Baxter Healthcare, where she was responsible for Europe, Africa and the Middle East. Louise joined Baxter Healthcare in 2000 as Vice President, Strategy & Business Development Europe. Before joining Baxter, she was Director of Global Ceramics at English China Clay and prior to that she held a variety of roles at ICI between 1985 and 1998. Louise has an MBA, and holds an MA in Natural Sciences and a PhD in Metallurgy from the University of Cambridge.
Rolf Soderstrom Chief Financial Officer Rolf Soderstrom, BA, ACA, joined BTG as Chief Financial Officer in December 2008 from Protherics PLC, where he was Finance Director from August 2007. From 2004, he was a Divisional Finance Director of Cobham plc, managing a portfolio of businesses across Europe and the US. From 2000 he was a Director of Corporate Finance at Cable & Wireless plc. Prior to this, he worked in the Corporate Recovery and Corporate Finance Department of PricewaterhouseCoopers after qualifying as a Chartered Accountant.
Peter Chambré Non-executive director Peter Chambré joined BTG as a non-executive director in September 2006 and he is a member of the Nomination, Audit and Remuneration Committees. Peter is Chairman of Axellia Pharmaceuticals AS, OneMed Group AB and 7TM Pharma A/S. He is also a non- executive director of Spectris plc, the precision instrumentation and controls company. Peter was Chief Executive Officer of Cambridge Antibody Technology Group plc from 2002 until its acquisition by AstraZeneca plc in 2006. Previously he was Chief Operating Officer of Celera Genomics Group and Chief Executive of Bespak plc.
Giles Kerr Non-executive director Giles Kerr joined BTG as a non-executive director in October 2007 and is the Company’s Senior Independent Director. He is Chairman of the Audit Committee and a member of the Nomination and Remuneration Committees. Giles is currently the Director of Finance with the University of Oxford, UK. He is also a Director of Victrex plc, Elan Corporation plc and Isis Innovation Ltd. Previously Giles was the Group Finance Director and Chief Financial Officer of Amersham plc, acquired by GE Healthcare in 2004. Prior to his role at Amersham, he was a partner with Arthur Andersen in the UK. He is a graduate of the University of York and a Fellow of the Institute of Chartered Accountants in England and Wales.
Melanie Lee Non-executive director Melanie Lee, PhD, CBE, FMedSci, DSc (Hons), joined BTG as a non-executive director in November 2010 and she is a member of the Remuneration Committee. Melanie is the CEO of Syntaxin Limited, a biotechnology company developing novel biopharmaceuticals to control cell secretion, and Founder and Director of the pharmaceutical consultancy Think10. She also chairs the board of Cancer Research Technology Limited, the technology development and commercialisation arm of Cancer Research UK. Melanie was formerly President of New Medicines and Executive VP R&D with UCB, having been R&D Director and a member of the board of Celltech plc.
Ian Much Non-executive director Ian Much joined BTG as a non-executive director in August 2010. He is Chairman of the Remuneration Committee and a member of the Audit Committee. Ian is currently a non- executive director and the senior independent director of Chemring Group PLC, Senior plc and Simplyhealth Group. Ian was Chief Executive of De La Rue plc between 1998 and 2004 and Chief Executive of T&N plc between 1996 and 1998. Previous non-executive director appointments include Manchester United plc, Camelot plc and Admiral plc.
James O’Shea Non-executive director Jim O’Shea joined BTG as a non-executive director in April 2009 and he is a member of the Nomination and Remuneration Committees. He is a director of Zalicus Inc and a former Chairman of the US National Pharmaceuticals Council. From 2007 to 2008, he was Vice Chairman of Sepracor, Inc, where he was also President and Chief Operating Officer from 1999 to 2007. Previously Jim was Senior Vice President of Sales & Marketing and Medical Affairs for Zeneca Pharmaceuticals (US), a business unit of Zeneca Inc. While at Zeneca, he held several management positions of increasing responsibility in international sales and marketing in the US and the UK.